Collapsible/expandable tubular electrode leads

ABSTRACT

A medical lead and method of treating a patient are provided. The medical lead comprises an electrically insulative tubular membrane, a resilient spring element associated with the insulative membrane, and at least one electrode associated with the insulative membrane. The medical lead is configured to be collapsed into a compact form for percutaneous delivery into the patient, thereby obviating the need to perform an invasive surgical procedure on the patient. The body formed by these elements, when expanded, can be sized to fit within the epidural space of a patient. The patient can be treated by placing the medical lead into a collapsed state by applying a compressive force to the medical lead, percutaneously delivering the collapsed medical lead into the patient adjacent tissue to be treated, and placing the medical lead into an expanded state by releasing the compressive force.

RELATED APPLICATIONS

This application is a continuation of copending U.S. patent applicationSer. No. 10/799,295, filed on Mar. 12, 2004, which is related to U.S.patent application Ser. No. 10/799,270, filed on Mar. 12, 2004, both ofwhich are expressly incorporated herein by reference.

FIELD OF THE INVENTION

The invention relates to the implantation of electrode leads within apatient, and in particular, the implantation of stimulation electrodeleads within a patient's spine to treat disorders, such as chronic pain.

BACKGROUND OF THE INVENTION

It is known to treat chronic pain by electrically stimulating the spinalcord, spinal nerve roots, and other nerve bundles. Although not fullyunderstood, the application of electrical energy to particular regionsof the spinal cord induces parasthesia (i.e., a subjective sensation ofnumbness or tingling) in the afflicted body regions associated with thestimulated spinal regions. This parasthesia effectively masks thetransmission of chronic pain sensations from the afflicted body regionsto the brain. Since each body region is associated with a particularspinal nerve root, it is important that stimulation be applied at theproper longitudinal position along the spinal cord to provide successfulpain management and avoid stimulation of unaffected regions of the body.Also, because nerve fibers extend between the brain and the nerve rootsalong the same side of the spine as the body regions they control, it isequally important that stimulation be applied at the proper lateralposition of the spinal cord. For example, to treat unilateral pain(i.e., pain sensed only on one side of the body), electrical stimulationis applied to the corresponding side of the spinal cord. To treatbilateral pain (i.e., pain sensed on both sides of the body), electricalstimulation is either applied directly to the midline of the spinal cordor applied to both lateral sides of the spinal cord.

In a typical procedure, one or more stimulation leads are introducedthrough the patient's back into the epidural space under fluoroscopy.The specific procedure used to implant the stimulation lead willultimately depend on the type of stimulation lead used. Currently, thereare two types of commercially available stimulation leads: apercutaneous lead and a surgical lead.

A percutaneous lead comprises a cylindrical body with ring electrodes,and can be introduced into contact with the affected spinal tissuethrough a Touhy-like needle, which passes through the skin, between thedesired vertebrae, and into the spinal cavity above the dura layer. Forunilateral pain, a percutaneous lead is placed on the correspondinglateral side of the spinal cord. For bilateral pain, a percutaneous leadis placed down the midline of the spinal cord, or two percutaneous leadsare placed down the respective sides of the midline.

A surgical lead has a paddle on which multiple electrodes are arrangedin independent columns, and is introduced into contact with the affectedspinal tissue using a surgical procedure, and specifically, alaminectomy, which involves removal of the laminar vertebral tissue toallow both access to the dura layer and positioning of the lead.

After the stimulation lead(s) (whether percutaneous or surgical) areplaced at the target area of the spinal cord, the lead(s) are anchoredin place, and the proximal ends of the lead(s), or alternatively leadextensions, are passed through a tunnel leading to a subcutaneous pocket(typically made in the patient's abdominal area) where a neurostimulatoris implanted. The lead(s) are connected to the neurostimulator, which isthen operated to test the effect of stimulation and adjust theparameters of the stimulation for optimal pain relief. During thisprocedure, the patient provides verbal feedback regarding the presenceof paresthesia over the pain area. Based on this feedback, the leadposition(s) may be adjusted and re-anchored if necessary. Any incisionsare then closed to fully implant the system.

Various types of stimulation leads (both percutaneous and surgical), aswell as stimulation sources and other components, for performing spinalcord stimulation are commercially available from Medtronic, Inc.,located in Minneapolis, Minn., and Advanced Neuromodulation Systems,Inc., located in Plano, Tex.

The use of surgical leads provides several functional advantages overthe use of percutaneous leads. For example, the paddle on a surgicallead has a greater footprint than that of a percutaneous lead. As aresult, an implanted surgical lead is less apt to migrate from itsoptimum position than is an implanted percutaneous lead, therebyproviding a more efficacious treatment and minimizing post operativeprocedures otherwise required to reposition the lead. As anotherexample, the paddle of a surgical lead is insulated on one side. As aresult, almost all of the stimulation energy is directed into thetargeted neural tissue. The electrodes on the percutaneous leads,however, are entirely circumferentially exposed, so that much of thestimulation energy is directed away from the neural tissue. Thisultimately translates into a lack of power efficiency, wherepercutaneous leads tend to exhaust a stimulator battery supply 25%-50%greater than that exhausted when surgical leads are used. As stillanother example, the multiple columns of electrodes on a surgical leadare well suited to address both unilateral and bilateral pain, whereelectrical energy may be administered using either column independentlyor administered using both columns.

Although surgical leads are functionally superior to percutaneous leads,there is one major drawback—surgical leads require painful surgeryperformed by a neurosurgeon, whereas percutaneous leads can beintroduced into the epidural space minimally invasively by ananesthesiologist using local anesthesia.

There, thus, remains a need for a minimally invasive means ofintroducing stimulation leads within the spine of a patient, whilepreserving the functional advantages of a surgical lead.

SUMMARY OF THE INVENTION

In accordance with a first aspect of the present inventions, a medicallead is provided. The medical lead comprises an electrically insulativetubular membrane having an inner surface and an outer surface, aresilient spring element, and at least one electrode mounted. The springelement is associated with the membrane, e.g., by forming or mountingthe spring element onto the membrane, or embedding the spring elementinto the membrane, and the electrode(s) is associated with the outersurface of the membrane, e.g., by forming or mounting the electrode(s)onto the outer surface, or embedding the springelement into the outersurface. The spring element can be associated with the inner surface orthe outer surface of the insulative membrane.

The insulative membrane can be, e.g., continuous, porous, or meshed. Theinsulative membrane can take on a variety of tubular shapes. Forexample, the tubular shape can exhibit a circular, rectangular,triangular, or irregular geometry. In one embodiment, the insulativemembrane is allowed to be flaccid and has a relatively low-stiffness, sothat it can be made as thin as possible to facilitate collapsing of themedical lead into a low-profile geometry. The spring element isconfigured to expand the insulative membrane. The spring element can be,e.g., a discrete element or can be formed of a mesh or braid.

In one embodiment, the medical lead is configured to inhibit tissuegrowth. If associated with the inner surface of the insulative membrane,the spring element can be formed of any suitable resilient material,since it is not exposed to tissue. If associated with the outer surfaceof the insulative membrane, however, the spring element is preferablyformed of a material that inhibits tissue growth. For example, in thiscase, the spring element can be formed of a continuous layer ofmaterial. In this manner, the implanted medical lead can be more easilyretrieved from the patient's body, if necessary. The medical lead ispreferably configured to be collapsed into a compact form forpercutaneous delivery into the patient, thereby obviating the need toperform an invasive surgical procedure on the patient. The medical lead,when expanded, can be sized to fit within the epidural space of apatient.

In accordance with a second aspect of the present inventions, anothermedical lead is provided. The medical lead comprises a resilient tubularstructure having a normally non-circular cross-sectional shape (e.g., arectangle, oval, or crescent), and at least one electrode associatedwith the tubular structure. The tubular structure may comprise, e.g., adiscrete element or can be formed of a mesh or braid. In one embodiment,the medical lead is configured to inhibit tissue growth. The medicallead is preferably configured to be collapsed into a compact form forpercutaneous delivery into the patient, thereby obviating the need toperform an invasive surgical procedure on the patient. The medical lead,when expanded, can be sized to fit within the epidural space of apatient. In this case, the non-cylindrical geometry of the tubularstructure allows the tubular structure to conform to the non-cylindricalshaped epidural space, so that, when expanded, painful tissuedisplacement is minimized.

In accordance with a third aspect of the present inventions, a method oftreating a patient with one of the previously described medical leads isprovided. The method comprises placing the medical lead into a collapsedstate by applying a compressive force to the medical lead,percutaneously delivering the collapsed medical lead into the patientadjacent tissue to be treated, and placing the medical lead into anexpanded state by releasing the compressive force. In one preferredmethod, the medical lead is used to stimulate tissue, such as spinalcord tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of preferredembodiment(s) of the invention, in which similar elements are referredto by common reference numerals. In order to better appreciate theadvantages and objects of the invention, reference should be made to theaccompanying drawings that illustrate the preferred embodiment(s). Thedrawings, however, depict the embodiment(s) of the invention, and shouldnot be taken as limiting its scope. With this caveat, the embodiment(s)of the invention will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1 is a plan view of a stimulation lead kit arranged in accordancewith a preferred embodiment of the present invention;

FIG. 2 is a cross-sectional view of a stimulation paddle used in the kitof FIG. 1, particularly shown in a low-profile collapsed geometry;

FIG. 3 is a cross-sectional view of the stimulation paddle used in thekit of FIG. 1, particularly shown in another low-profile collapsedgeometry;

FIG. 4 is a cross-sectional view of the stimulation paddle used in thekit of FIG. 1, particularly shown in still another low-profile collapsedgeometry;

FIG. 5 is a cross-sectional view of a planar stimulation paddle that canbe used in the kit of FIG. 1, taken along the line 5-5;

FIG. 6 is a cross-sectional view of a curviplanar stimulation paddlethat can be used in the kit of FIG. 1, taken along the line 6-6;

FIG. 7 is a top view of the stimulation paddle used in the kit of FIG.1;

FIG. 8 is a top view of another stimulation paddle that can be used inthe kit of FIG. 1;

FIG. 9 is a top view of still another stimulation paddle that can beused in the kit of FIG. 1;

FIG. 10 is a top view of yet another stimulation paddle that can be usedin the kit of FIG. 1;

FIG. 11 is a top view of yet another stimulation paddle that can be usedin the kit of FIG. 1;

FIG. 12 is a top view of yet another stimulation paddle that can be usedin the kit of FIG. 1;

FIG. 13 is a top view of yet another stimulation paddle that can be usedin the kit of FIG. 1;

FIG. 14 is a perspective view of a stimulation tube that can be used inthe kit of FIG. 1;

FIG. 15 is a cross-sectional view of the stimulation tube of FIG. 14,particularly showing its cross-sectional rectangle shape when placed inan expanded geometry;

FIG. 16 is a cross-sectional view of an alternative stimulation tube,particularly showing its cross-sectional oval shape when placed in anexpanded geometry;

FIG. 17 is a cross-sectional view of another alternative stimulationtube, particularly showing its cross-sectional crescent shape whenplaced in an expanded geometry;

FIG. 18 is a cross-sectional view of the stimulation tube of FIG. 14,particularly shown in a low-profile collapsed geometry;

FIG. 19 is a perspective view of another stimulation tube that can beused in the kit of FIG. 1;

FIG. 20 is a cross-sectional view of the stimulation tube of FIG. 19,taken along the line 20-20; and

FIGS. 21A-21D are various views illustrating the installation of the kitof FIG. 1 into a patients spine.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to FIG. 1, a spinal cord stimulation lead kit 100 arrangedin accordance with one preferred embodiment of the present invention isshown. In its simplest form, the stimulation kit 100 generally comprisesa stimulation lead 102, which is configured to be percutaneouslydelivered and implanted into the epidural space of a patient's spine, animplantable electrical stimulation source 104 configured for deliveringstimulation energy to the stimulation lead 102, and an optionalextension lead 106 configured for connecting the stimulation lead 102 tothe remotely implanted stimulation source 104.

It should be noted that although the kit 100 illustrated in FIG. 1 isdescribed herein as being used in spinal cord stimulation (SCS) for thetreatment of chronic pain, the kit 100, or a modification of the kit100, can be used in an SCS procedure to treat other ailments, or canused in other applications other than SCS procedures, such as peripheralnervous system stimulation, sacral root stimulation, and brain tissuestimulation, including cortical and deep brain stimulation. In thelatter case, the stimulation lead 102 can be delivered through aminiature cranial burr hole into the brain tissue.

The stimulation lead 102 comprises an elongated sheath body 108 having aproximal end 110 and a distal end 112. The sheath body 108 is composedof a suitably flexible material (such as polyurethane, silicone, etc.),which may either be resilient or non-resilient, and may be formed via anextrusion process or by any other suitable means. In the illustratedembodiment, the sheath body 108 is cylindrically-shaped and sized to fitthrough a Touhy-like needle (not shown). In this case, the diameter ofthe sheath body 108 is preferably less than 5 mm to allow it to bepercutaneously introduced through a needle. More preferably, thediameter of the sheath body 108 is within the range of 1 mm to 3 mm, sothat the stimulation lead 102, along with the secondary stimulationleads 104 described below, can comfortably fit within the epidural spaceof the patient. The sheath body 108 may have other cross-sectionalgeometries, such as oval, rectangular, triangular, etc. If rectangular,the width of the stimulation lead 102 can be up to 5 mm, since the widthof an epidural space is greater than its height. The sheath body 108 mayhave an optional lumen (not shown) for receiving an obturator (notshown) that axially stiffens the sheath body 108 to facilitatepercutaneous introduction of the stimulation lead 102 within theepidural space of the patient's spine, as will be described in furtherdetail below.

The stimulation lead 102 further comprises a plurality of terminals 114(in this case, four) mounted on the proximal end 110 of the sheath body108. The terminals 114 are formed of ring-shaped elements composed of asuitable biocompatible metallic material, such as platinum,platinum/iridium, stainless steel, gold, or combinations or alloys ofthese materials, and can be mounted to the sheath body 108 in aninterference fit arrangement.

The stimulation lead 102 further comprises a stimulation paddle 116suitably mounted to the distal end 112 of the sheath body 108. In thisembodiment, the stimulation paddle 116 is laterally centered on thesheath body 108, but as will be discussed below, the electrode paddle116 can alternatively be laterally offset from the sheath body 108. Aswill be described in further detail below, the stimulation paddle 116 isconfigured to be placed into a compact, low-profile geometry by, e.g.,rolling (see FIG. 2) or folding (see FIGS. 3 and 4) the paddle 116, andmaintained in this low-profile geometry by applying a radial compressiveforce to the paddle 116, such as the force that would be applied by thelumen of a delivery device. Upon release of the radial compressiveforce, such as when the paddle 116 exits the delivery device, the paddle116 springs open into its normally expanded geometry. In the illustratedembodiment, the paddle 116 expands into a planar geometry, asillustrated in FIG. 5. Alternatively, the paddle 116 can expand into acurviplanar geometry (i.e., a plane existing in three-dimensional space,e.g., a plane having an arcuate, curved, or undulating shape), asillustrated in FIG. 6.

Referring further to FIG. 7, the stimulation paddle 116 comprises apaddle-shaped membrane 118 having a surface 124, an array of electrodes120 mounted on the membrane surface 124, and a skeletal spring element122 mounted on the membrane surface 124 between the electrodes 120.Alternatively, the electrodes 120 and skeletal spring element 122 can berespectively formed onto oppositely disposed surfaces of the membrane118, so that the routing of the spring element 122 can be accomplishedindependently of the electrodes 120. To prevent or inhibit tissue growthafter the stimulation lead 102 is implanted, the surface of thestimulation paddle 116 is preferably smooth and free of discontinuitiesthat would otherwise be found in tissue growth exhibiting surfaces, suchas mesh or braided material. In this manner, the implanted lead 102 canbe more easily and percutaneously removed if necessary.

The electrodes 120 can be formed onto the membrane 118 using knowndeposition processes, such as sputtering, vapor deposition, ion beamdeposition, electroplating over a deposited seed layer, or a combinationof these processes. Alternatively, the electrodes 120 can be formed ontothe membrane 118 as a thin sheet or foil of electrically conductivemetal. Or, the electrodes 120 can be discrete elements that are embeddedinto the membrane 118, such that they lie flush with the surface 124 ofthe membrane 118. The electrodes 120 can be composed of the sameelectrically conductive and biocompatible material as the terminals 114,e.g., platinum, platinum/iridium, stainless steel, gold, or combinationsor alloys of these materials. In the embodiment illustrated in FIG. 7,the electrodes 120 are arranged in a single column of four elementsextending along the midline of the membrane 118. As will be described infurther detail below, the electrodes 120 can have other configurations.In the illustrated embodiment, the electrodes 120 are circular, but canbe formed as other geometric shapes, such as rectangular or ellipsoidal.

The stimulation lead 102 further comprises a plurality of conductors(not shown) extending through the sheath body 108 and membrane 118 andconnecting each electrode 120 with a respective terminal 114. Theconductors 122 are composed of a suitably electrically conductivematerial that exhibits the desired mechanical properties of lowresistance, corrosion resistance, flexibility, and strength.

In the illustrated embodiment, the membrane 118 is composed of acontinuous layer of material, although alternatively, the membrane 118may be porous, meshed, or braided. Whether continuous or not, thematerial from which the membrane 118 is composed is relatively thin(e.g., 0.1 mm to 2 mm, although 1 mm or less is most preferred) and hasa relatively low-stiffness. Exemplary materials are low-stiffnesssilicone, expanded polytetrafluoroethylene (ePTFE), or urethane. Due tothese properties, the stimulation paddle 116 can be more easilycollapsed into a low-profile geometry. For example, the stimulationpaddle 116 can be rolled (see FIG. 2), or folded along one or more foldlines (see FIGS. 3 and 4). Although these properties allow thestimulation paddle 116 to be more easily collapsed into a low-profilegeometry, thereby facilitating percutaneous delivery of the lead 102,these same properties also cause the membrane 118 to be too flaccid toeasily spring open from the low-profile geometry. Radio-opaque markers(not shown) may optionally be provided on the membrane 118, so that thestimulation paddle 116 may be more easily navigated and placed into theepidural space of the patient under fluoroscopy.

The skeletal spring element 122, however, advantageously provides thisnecessary spring force. In particular, the spring element 122 iscomposed of a relatively high-stiffness and resilient material, such asstainless steel, a metallic and polymer material, or a high-stiffnessurethane or silicone, that is shaped into a normally planar(curviplanar) geometry. In alternative embodiments, the spring element122 may be composed of a shape memory material, such as nitinol, so thatit assumes a planar (or curviplanar) geometry in the presence of adefined temperature, such as, e.g., body temperature. Thus, it can beappreciated that the normally planar (or curviplanar) geometry of thespring element 122 will cause the stimulation paddle 116 to likewiseassume a planar (curviplanar) geometry in the absence of an externalforce (in particular, a compressive force). In the illustratedembodiment, the spring element 122 is formed of a thin layer of materialthat is laminated onto the membrane 118. In effect, the spring element122 has a two-dimensional geometry in that it has a length and a width,but a minimal thickness. As a result, protrusions from the membrane 118are avoided, thereby allowing the stimulation paddle 116 to be placedinto a lower collapsed profile. Alternatively, the spring element 122can be made from wire, which is cylindrical in nature, and thus, can besaid to have a three-dimensional geometry. Whether formed from a layerof material or a wire, the spring element 122 may alternatively beembedded into the membrane 118, so that the surface of the springelement 122 is flush with the surface 124 of the membrane 118.

As can be seen in FIG. 7, the spring element 122 is formed of a singlelinear element that longitudinally extends along the membrane 118 in ameandering fashion between the electrodes 120. In this case, thelaterally extending curves of the meandering spring element 122 act ascross-supports that provide the necessary spring force to urge thestimulation paddle 116 from its low-profile collapsed geometry into itsexpanded geometry. Notably, the end of the spring element 122 is beadedto prevent inadvertent perforation of the membrane 118 when thestimulation paddle 116 is mechanically stressed.

The spring element 122 can have other geometries. For example, FIG. 8illustrates a stimulation paddle 126 that comprises a skeletal springelement 132 that includes a main spring segment 134 that is similar tothe spring element 122 illustrated in FIG. 7, and additional secondaryspring segments 135 that extend longitudinally from the apexes of themain spring segment curves. The longitudinally extending secondaryspring segments 135 provide additional axial stiffness to thestimulation paddle 126, thereby facilitating axial movement (i.e., thepushability) of the expanded stimulation paddle 126 by minimizing axialbuckling of the membrane 118. To prevent inadvertent perforation of theinsulative membrane 118, the distal ends of the secondary springsegments 135 are beaded.

As another example, FIG. 9 illustrates a stimulation paddle 136 having askeletal spring element 122 that includes a main spring segment 144 thatextends longitudinally along the centerline of the membrane 118, and aplurality of lateral spring segments 145 that branch off of the mainspring segment 144 between the electrodes 120. As can be seen in FIG. 9,the electrodes 120 are arranged as two columns of four elements eachextending down the lateral sides of the membrane 118. Besides providinga structure from which the lateral spring segments 144 are supported,the main spring segment 144 provides axial stiffness to the stimulationpaddle 146, thereby facilitating axial movement (i.e., the pushability)of the expanded stimulation paddle 146 by minimizing axial buckling ofthe membrane 118. To this end, the main spring segment 144 is somewhatwider than the lateral spring segments 145. The lateral spring segments145 act as cross-members that urge the membrane 118 into its normallyexpanded state, thereby providing the spring force that transforms thecollapsed membrane 118 into the expanded geometry in the absence of acompressive force.

FIG. 10 illustrates a stimulation paddle 146 that comprises a skeletalspring element 152, which is similar to the previously described springelement 152, with the exception that it comprises lateral staggeredspring segments 155 that are not linear, but are rather formed into twodimensional shapes—in this case a leaf shape. This increased size of thelateral spring segments 155 provides increased lateral spring force tothe stimulation paddle 146. In this case, the number of lateral segments155 are decreased, and the electrodes 120 are arranged into two columnsof two elements each.

FIG. 11 illustrates a stimulation paddle 156 that comprises a skeletalspring element 162 with a plurality of diamond-shaped elements 164longitudinally extending down the midline of the membrane 118 and aplurality of innerconnecting segments 165 between the respectivediamond-shaped elements 164. The electrodes 120 are arranged in a singlecolumn of four electrodes 120 that extend down the midline of themembrane 118 between the respective diamond-shaped elements 164. Theinterconnecting segments 165 are curved in alternating left and rightlateral directions in order to accommodate the centered electrodes 120.

FIG. 12 illustrates a stimulation paddle 166 that comprises a skeletalspring element 172 with a trunk segment 173, two main spring segments174 that longitudinally extend from the trunk segment 173 along the leftand right lateral sides of the membrane 118, and lateral spring segments175 that branch off of the main spring segments 174 towards the midlineof the membrane 118. Like the main spring segment 144 of the stimulationpaddle 136 illustrated in FIG. 9, the main spring segments 174 provideaxial rigidity to the stimulation paddle 166, while providing astructure supporting the lateral spring segments 175. Like the lateralspring segments 175 of the stimulation paddle 166 illustrated in FIG.11, the lateral spring segments 175 act as cross members that facilitatetransformation of the stimulation paddle 166 from its collapsed geometryinto its expanded geometry. To prevent inadvertent perforation of theinsulative membrane 118, the distal ends of the main spring segments 174and secondary spring segments 175 are beaded. The electrodes 120 arearranged in a single column of four electrodes 120 extending down themidline of the membrane 118 between the respective secondary springsegments 175.

FIG. 13 illustrates a stimulation paddle 176 that comprises a membrane118 that is laterally offset from the distal end 112 of the elongatedsheath 108, and a skeletal spring element 182 with a main spring segment184 that longitudinally extends along the membrane 118 and lateralspring segments 185 that laterally branch off from the main springsegment 184 towards the other lateral side of the membrane 118. The mainspring segment 184 and lateral spring segments 185 function in the samemanner as the main spring segment 144 and lateral spring segments 145 ofthe spring element 132 illustrated in FIG. 9. To prevent inadvertentperforation of the insulative membrane 118, the distal ends of thesecondary spring segments 185 are beaded. The electrodes 120 arearranged in a single column of four elements that longitudinally extenddown the midline of the membrane 118 between the lateral spring segments185.

Although all of the stimulation paddles illustrated in FIGS. 7-13 havesingle spring elements, stimulation paddles with multiple springelements can also be provided. In addition, tubular designs, which are,in effect, stimulation paddles that are wrapped around onto themselves,can be formed, in order to provide a more stable and snug engagementwithin the epidural space.

In particular, FIGS. 14 and 15 illustrate a stimulation lead 202 thatcan alternatively be used in the kit 100 of FIG. 1. The stimulation lead202 is similar to the stimulation 102 described above, with theexception that it comprises a stimulation tube 216, rather than astimulation paddle. The stimulation tube 216 comprises a tubular, andspecifically, rectangular cross-sectional shaped, membrane 218 having anouter surface 224, an array of electrodes 220 mounted on the outersurface 224, and skeletal spring elements 222 mounted on, the outersurface 224 between the electrodes 220. Alternatively, the electrodes220 can be mounted on the outer surface 224, and the spring elements 222can be mounted on an inner surface of the tubular membrane 218, so thatthe routing of the spring element 222 can be accomplished independentlyof the electrodes 220. To prevent or inhibit tissue growth after thestimulation lead 202 is implanted, the outer surface 224 of thestimulation tube 216 is preferably smooth and free of discontinuitiesthat would otherwise be found in tissue growth exhibiting surfaces, suchas mesh or braided material. In this manner, the implanted lead 202 canbe more easily and percutaneously removed if necessary.

The electrodes 220 can be composed of the same material, shaped, andformed onto the membrane 218 in the same manner as the electrodes 120.In the embodiment illustrated in FIG. 14, the electrodes 220 arearranged in a single column of four elements longitudinally extendingalong one side of the membrane 218. Like the paddle membrane 118, thetubular membrane 218 is formed of a relatively thin (e.g., 0.1 mm to 2mm, although 1 mm or less is most preferred), and is composed of arelatively low-stiffness material, such that it can be collapsed into alow-profile geometry, as shown in FIG. 18. Also, like the paddlemembrane 118, the tubular membrane 218, by itself, is too flaccid toeasily spring open from the low-profile geometry. Again, the skeletalspring elements 222 provide this necessary spring force, so that thestimulation tube 216 can expand outward in the absence of an externalcompressive force. The spring elements 222 can be composed of the samematerial and can be formed onto the membrane 218 in the same manner asthe previously described spring element 122. In the embodimentillustrated in FIG. 14, each of the spring elements 222 extends aroundthe circumference of the tubular membrane 218 in a meandering fashion.Of course, other spring element configurations can be used.

Although the membrane 218 is illustrated as having a normally expandedrectangular geometry, as best shown in FIG. 15, the membrane 218 canalternatively have other non-cylindrical tube-like shapes. For example,FIG. 16 illustrates an alternative tubular membrane 216′ that has anoval cross-sectional shape, and FIG. 17 illustrates another tubularmembrane 216″ that has a crescent cross-sectional shape. Thecrescent-shaped tubular membrane 216″ lends itself particular well tospinal cord stimulation, since the spinal cord can be comfortably seatedwithin a concave region 216 of the tubular membrane 216″.

FIGS. 19 and 20 illustrate another stimulation tube 236 that is similarto the stimulation tube 216, with the exception that, rather than havingdiscrete spring elements, it comprises a resilient spring element 242formed of a mesh or braid that may be composed of the same base materialas the previously described spring elements. The tube 236 also has anoval cross-sectional shape, rather than a rectangular cross-sectionalshape. The spring element 242 is formed on an inner surface of thetubular membrane 218, so that the mesh or braid material is not incontact with tissue, and therefore does not inhibit tissue growth. Likethe spring element 222, the spring element 242 serves to urge thetubular membrane 218 from a low-profile collapsed geometry to anexpanded geometry. As shown in FIG. 19, the distal and proximal ends ofthe stimulation tube 236 are tapered to allow for a safer deploymentand, if necessary, retrieval of the device.

Referring back to FIG. 1, the implantable stimulation source 104 isdesigned to deliver electrical pulses to the stimulation lead 102 inaccordance with programmed parameters. In the preferred embodiment, thestimulation source 104 is programmed to output electrical pulses havingamplitudes varying from 0.1 to 20 volts, pulse widths varying from 0.02to 1.5 milliseconds, and repetition rates varying from 2 to 2500 Hertz.In the illustrated embodiment, the stimulation source 104 takes the formof a totally self-contained generator, which once implanted, may beactivated and controlled by an outside telemetry source, e.g., a smallmagnet. In this case, the pulse generator has an internal power sourcethat limits the life of the pulse generator to a few years, and afterthe power source is expended, the pulse generator must be replaced.Generally, these types of stimulation sources 106 may be implantedwithin the chest or abdominal region beneath the skin of the patient.

Alternatively, the implantable stimulation source 104 may take the formof a passive receiver that receives radio frequency (RF) signals from anexternal transmitter worn by the patient. In this scenario, the life ofthe stimulation source 104 is virtually unlimited, since the stimulationsignals originate from the external transmitter. Like the self-containedgenerators, the receivers of these types of stimulation sources 106 canbe implanted within the chest or abdominal region beneath the skin ofthe patient. The receivers may also be suitable for implantation behindthe ear of the patient, in which case, the external transmitter may beworn on the ear of the patient in a manner similar to that of a hearingaid. Stimulation sources, such as those just described, are commerciallyavailable from Advanced Neuromodulation Systems, Inc., located in Plano,Tex., and Medtronic, Inc., located in Minneapolis, Minn.

The optional extension lead 106 comprises an elongated sheath body 109having a proximal end 111 and a distal end 113, much like the sheathbody 108 of the stimulation lead 102, a proximal connector 115 coupledto the proximal end 113 of the sheath body 109, a distal connector 117coupled to the distal end 111 of the sheath body 109, and a plurality ofelectrical conductors (not shown) extending through the sheath body 109between the proximal and distal connectors 115/117. The length of theextension lead 102 is sufficient to extend from the spine of thepatient, where the proximal end of the implanted stimulation lead 102protrudes from to the implantation site of the stimulation source104—typically somewhere in the chest or abdominal region. The proximalconnector 115 is configured to be coupled with to the stimulation source104, and the distal connector 117 is configured to mate with theproximal end of the stimulation lead 102.

Having described the stimulation lead kit 100, its installation and usein treating chronic pain will now be described with reference to FIGS.21A-21D. After the patient has been prepared (which may involve testingthe efficacy of spinal cord stimulation on the patient, and, oncedetermining that the patient can be effectively treated with spinal cordstimulation, identifying and marking the appropriate vertebral intervalson the patient's skin and applying a local anesthetic to this region), aneedle 10, such as, e.g., a Touhy needle, is inserted through thepatient's skin 12 between the desired vertebrae 14, and into theepidural space 16 within the spine at a position inferior to targetstimulation site 18 (FIG. 21A). In the illustrated method, the Touhyneedle 10 will serve as the primary delivery mechanism for thestimulation lead 102. Alternatively, if an optional introducer (notshown) is used, a guide wire (not shown) is introduced through theneedle 10 and advanced to or near the target stimulation site 18. Theneedle 10 is removed, the introducer is then introduced over the guidewire and advanced to the target stimulation site 18, and the guide wireis then withdrawn. In this case, the introducer will serve as theprimary delivery mechanism for the stimulation lead 102.

After the deliver mechanism is in place, the stimulation lead 102, withthe stimulation paddle 116 collapsed into a low-profile geometry (seeFIGS. 2-4), is then inserted through the needle or the introducer(whichever is in place), and positioned in the epidural space 16 at thetarget stimulation site 18 (FIGS. 21B and 21C). The stimulation tubes216/236 can be inserted through the needle or the introducer in the samemanner. If the stimulation lead 102 has an obturator lumen, an obturatorcan be used to provide additional axial stiffness and to facilitatecontrol. Once the compressive radial force applied by the deliverydevice is released, the stimulation paddle 116 expands into its normallyplanar geometry, with the electrodes 120 facing the dural layer 20 andspanning the midline of the spinal cord 22 (FIG. 21D). If stimulationtubes 216/236 are used, their two-dimensional expansion will provide amore secure engagement within the epidural space. Notably, the use ofnon-cylindrical stimulation tubes, when expanded, conform better to thenon-cylindrical epidural space 16, thereby minimizing painful tissuedisplacement.

Next, the needle 10 or introducer is removed, and the proximal end ofthe stimulation lead 102 is connected to a tester (not shown), which isthen operated in a standard manner to confirm proper location of thestimulation lead 102 and to adjust the stimulation parameters foroptimal pain relief. Once this optimization process has been completed,the tester is disconnected from the stimulation lead 102, which is thenanchored in place using standard lead anchors (not shown). In the caseof stimulation tubes 216/236, anchors may not be necessary, since theyself-anchor themselves within the epidural space when expanded. Next,the stimulation lead 102 is coupled to the stimulation source 104 andimplantation is completed (not shown). In particular, a subcutaneouspocket is created in the patients abdominal area for implantation of thestimulation source 104, and a tunnel is subcutaneously formed betweenthe spine region and the subcutaneous pocket. The optional leadextension 106 is passed through the tunnel, after which the adapter 154of the extension 106 is connected to the proximal end of the stimulationleads 102 and the connector 156 of the lead extension 106 is connectedto the stimulation source 104. The stimulation source 104 is programmedand tested, and then placed within the subcutaneous pocket, after whichall incisions are closed to effect implantation of the stimulation lead102 and stimulation source 104. The stimulation source 104 can then beoperated to convey stimulation energy from the stimulation source 104 tothe electrodes 120 of the stimulation lead 102, where it is, in turn,conveyed into the neural tissue for pain relief.

It can be appreciated that the relatively large footprint made by thestimulation lead 102, much like a prior art surgical lead, provides amore stable platform for the electrodes 120. Also, like a prior artsurgical lead, the electrodes 120 face in a single direction, therebyfocusing the stimulation energy into the affected neural tissue where itis needed. Unlike a surgical lead, however, the stimulation lead 102 canbe percutaneously delivered into the patient's spine in a minimallyinvasive and relatively pain-free manner, without requiring extensivepatient recovery.

Although particular embodiments of the present invention have been shownand described, it should be understood that the above discussion is notintended to limit the present invention to these embodiments. It will beobvious to those skilled in the art that various changes andmodifications may be made without departing from the spirit and scope ofthe present invention. Thus, the present invention is intended to coveralternatives, modifications, and equivalents that may fall within thespirit and scope of the present invention as defined by the claims.

1-6. (canceled)
 7. A medical lead, comprising: an electricallyinsulative membrane having a first stiffness; a resilient skeletalspring layer associated with the insulative membrane, wherein the springlayer wraps around onto itself and has a second stiffness greater thanthe first stiffness; and at least one electrode associated with theinsulative membrane.
 8. The medical lead of claim 7, wherein theinsulative membrane is flaccid.
 9. The medical lead of claim 7, whereinthe insulative membrane is tube-shaped.
 10. The medical lead of claim 7,wherein the spring layer is configured to urge the insulative membraneinto a curviplanar geometry.
 11. The medical lead of claim 7, whereinthe insulative membrane has two opposing surfaces, the spring layer isassociated with one of the two surfaces, and the at least one electrodeis associated with the other of the two surfaces.
 12. The medical leadof claim 7, wherein the insulative membrane has two opposing surfaces,and the spring layer and the at least electrode are associated with thesame one of the two surfaces.
 13. The medical lead of claim 7, whereinthe insulative membrane has an inner surface and an outer surface, andthe spring layer is associated with the outer surface of the insulativemembrane.
 14. The medical lead of claim 7, wherein the insulativemembrane has an inner surface and an outer surface, and the spring layeris associated with the inner surface of the insulative membrane.
 15. Themedical lead of claim 7, wherein the insulative membrane, spring layer,and at least one electrode form a body that is configured to inhibittissue growth.
 16. The medical lead of claim 7, wherein the insulativemembrane, spring layer, and at least one electrode form a body that isconfigured to be collapsed into a compact form for percutaneous deliveryinto a patient.
 17. The medical lead of claim 7, wherein the insulativemembrane, spring layer, and at least one electrode form an expanded bodythat is sized to fit within the epidural space of a patient.
 18. Themedical lead of claim 7, wherein the insulative membrane insulativemembrane has a normally non-cylindrical shape.
 19. The medical lead ofclaim 7, wherein the spring layer is a discrete element.
 20. The medicallead of claim 7, wherein the spring layer is a mesh or braid.
 21. Themedical lead of claim 7, wherein the spring layer is configured toexpand the insulative membrane.
 22. A method of treating a patient,comprising: placing the medical lead of claim 7 into a collapsed stateby applying a compressive force to the medical lead; percutaneouslydelivering the collapsed medical lead into the patient adjacent tissueto be treated; and placing the medical lead into an expanded state byreleasing the compressive force, whereby the resilient spring layerfacilitates expansion of the medical lead.
 23. The method of claim 22,further comprising stimulating the tissue with the medical lead.
 24. Themethod of claim 22, wherein the tissue is spinal cord tissue.